Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000076077
Ethics application status
Approved
Date submitted
18/01/2010
Date registered
20/01/2010
Date last updated
2/03/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Randomised Controlled Trial to determine the appropriate time to initiate peritoneal dialysis after insertion of catheter to minimise complications in end stage renal disease patients (Timely Peritoneal dialysis study)
Scientific title
Randomised Controlled Trial to determine the appropriate time to initiate peritoneal dialysis after insertion of catheter to minimise complications in end stage renal disease patients (Timely Peritoneal dialysis study )
Secondary ID [1] 288682 0
Nil known
Universal Trial Number (UTN)
N/A
Trial acronym
Timely PD study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chroinc kidney disease complications 256606 0
Condition category
Condition code
Renal and Urogenital 256774 256774 0 0
Kidney disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
1. All patients who met the inclusion and exclusion criteria and who underwent surgical peritoneal dialysis (PD) catheter insertion at the Royal Brisbane and Women’s Hospital (RBWH) and Rockhampton Base Hospital (RKH ) are invited to participate in the study. These participants were not on PD before and will be starting PD for the first time.
2. Tenckhoff curled PD catheters are inserted by the same surgical teams ( general surgery consultant /team) at each centre.

Participants were randomised to PD initiation interval, Group 1 (G1) commenced PD at one week, group 2 (G2) at two and group 3 (G3) at four weeks after insertion of PD catheter. Participants were also stratified by diabetic status.
All participants received formal PD training. Participants initiated PD with similar patterns of clinical practice apart from the randomised varying PD intervals. The PD catheter exit site and tunnel were examined according to standard clinical practice.
Intervention code [1] 255864 0
Treatment: Devices
Comparator / control treatment
Control Group is 2 weeks
Control group
Active

Outcomes
Primary outcome [1] 257649 0
Peritoneal fluid leaks and infection (over the four weeks following start up of peritoneal dialysis; Leak by observation during clinical examination; infection by chemical analysis of peritoneal dialysis fluid )
Timepoint [1] 257649 0
4 weeks from initiation of dialysis
Secondary outcome [1] 262910 0
Composite of all PD catheter related complications such as infection at exit site by clinical observation and will be confirmed by microbiological tests.
Timepoint [1] 262910 0
8 weeks from catheter insertion
Secondary outcome [2] 262912 0
Hemodialysis related complications such as infection and catheter related complications. These complications will be assessed by clinical examination/ tests
Timepoint [2] 262912 0
8 weeks from PD catheter insertion

Eligibility
Key inclusion criteria
1. end stage kidney disease
2. patients likely to start peritoneal dialysis in the 4 weeks after insertion of a Tenckhoff catheter
4.surgical or peritoneoscopic insertion of a Tenckhoff catheter
5.18 yrs or over
6. able to give informed consent
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. patients with a history of psychological illness or condition which interferes with their ability to understand or comply with the requirements of the study.
2.recent (within 4 weeks ) acute infection.
3. patients in whom peritoneal dialysis is contraindicated or not desired

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants are randomised to different arms . The participants are block randomised in equal proportions
to the three treatment groups using randomly
varying blocks The randomisation
sequence was generated using Stata 11 software .
Group 1 will start dialysis one week after Tenckhoff catheter
insertion, group 2 at two weeks and group 3 at four
weeks. A research nurse independent of study nurses and
physicians will undertake randomisation process.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation sequence was generated using Stata 11 software
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Participants will be stratified by site and diabetic status
Phase
Not Applicable
Type of endpoint/s
Safety
Statistical methods / analysis
To obtain 80% power with
an overall 1-sided significance level of 0.05, approximately
105 patients are required per group to establish
non-inferiority, defined as a difference in complication
rates less than 10% between two groups. It was assumed
that the expected complication rate was 3% as estimated
from the preliminary data, and the significance level was
adjusted for multiple comparisons.
Interim analysis was done

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
15/09/2008
Actual
15/09/2008
Date of last participant enrolment
Anticipated
31/12/2013
Actual
9/05/2013
Date of last data collection
Anticipated
Actual
Sample size
Target
315
Accrual to date
Final
122
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 256347 0
Government body
Name [1] 256347 0
Queensland Health
Country [1] 256347 0
Australia
Primary sponsor type
Hospital
Name
Queensland Health
Address
Department of Renal Medicine
Level 9 ,Ned Hanlon Building ,Butterfield street, Herston,Queensland,4029
Country
Australia
Secondary sponsor category [1] 251661 0
Commercial sector/Industry
Name [1] 251661 0
Baxter Clinical Educational Council
Address [1] 251661 0
Renal Division
Baxter Healthcare Corporation
T: +1.450.226.3273 direct
T: +1.847.473.6193 McGaw Park
M: +1.450.240.5330
F: +1.847.473.6903
Country [1] 251661 0
United States of America

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258418 0
Royal Brisbane and women's Hospitals Research and Ethics Committee
Ethics committee address [1] 258418 0
Level 7, Block 7
Royal Brisbane and Women's Hospital
HERSTON QLD 4029
Ethics committee country [1] 258418 0
Australia
Date submitted for ethics approval [1] 258418 0
22/10/2007
Approval date [1] 258418 0
02/02/2008
Ethics approval number [1] 258418 0
HREC/RBWH/ 2007/171

Summary
Brief summary
The planned study targets patients with end stage kidney disease who choose peritoneal dialysis for maintenance therapy. Current practice at the Royal Brisbane and Women's Hospital is to wait four weeks after a Teckhoff catheter is placed before starting peritoneal dialysis . The literature lacks evidence of the optimal interval between peritoneal catheter insertion and start up of dialysis. Consequently practice varies. They too support delayed use but do not test different delay intervals and can not tell us the optimal time. A few recent studies reported a very low leak incidence after using catheter 1 week post insertion , attributed to a tight catheter securing. Any delay in starting PD results in temporary haemodialysis in patients who require immediate dailysis. Temporary haemodialysis requires a central venous access with attendant risk of complications. Temporary haemodialysis is more expensive than peritoneal dialysis . Therefore guidelines bodies, such as CARI (Caring for Australasians with Renal Impairment,), European Dialysis and Transplant Association-European Renal Association and International Society for Peritoneal Dialysis suggest a two week delay. They can can only publish suggestions based on the weak body of evidence, or lack thereof. CARI suggests randomised control trial as there is insufficient evidence for this to be a “guideline’’.
The primary objective of this study is to determine the safest and shortest time interval between surgical placement of a Tenckhoff catheter and starting dialysis. The hypothesis is that there is no difference in complication rates between one, two and four week time intervals. If equivalence is proven between one, two and four week time intervals, we could justifiably change practice. Benefits for future patients include shorter exposure to haemodialysis treatments and their complications and shorter duration of haemodialysis catheter placement and its complications. If the results show more complications in the one or two week time interval groups, then we would encourage re-visiting the guidelines. catheter placement and its complications.
Trial website
Trial related presentations / publications
Trial has been published at BMC Nephrology

Ranganathan D, Baer R, Fassett R, Williams N,., Watson M, Han T and Healy.H
Randomised Controlled Trail to Determine the appropriate time to initiate peritoneal Dialysis
Ranganathan D et al , BMC Nephrology 2010,11.11
Public notes

Contacts
Principal investigator
Name 30724 0
Dr Dwarakanathan Ranganathan
Address 30724 0
Department of Renal Medicine
Royal Brisbane & Women's Hospital
Butterfield Street
Herston QLD 4029
Country 30724 0
Australia
Phone 30724 0
+61736468576
Fax 30724 0
Email 30724 0
[email protected]
Contact person for public queries
Name 13971 0
Dr Dwarakanathan Ranganathan
Address 13971 0
Senior Consultant Nephrologist
Royal brisbane & Women's Hospitals
Herston. Queensland, 4029
Country 13971 0
Australia
Phone 13971 0
+61 -07-36368576
Fax 13971 0
+61- 07-36368572
Email 13971 0
[email protected]
Contact person for scientific queries
Name 4899 0
Dr Dwarakanathan Ranganathan
Address 4899 0
Senior Consultant Nephrologist
Royal brisbane &women's Hospitals
Herston. Queensland, 4029
Country 4899 0
Australia
Phone 4899 0
+61736468576
Fax 4899 0
+61736468572
Email 4899 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
Dimensions AIRandomised Controlled Trial to determine the appropriate time to initiate peritoneal dialysis after insertion of catheter to minimise complications (Timely PD study)2010https://doi.org/10.1186/1471-2369-11-11
EmbaseA randomized controlled trial to determine the appropriate time to initiate peritoneal dialysis after insertion of catheter (Timely PD study).2017https://dx.doi.org/10.3747/pdi.2016.00066
N.B. These documents automatically identified may not have been verified by the study sponsor.